Kornimate/medical-research-clean huggingface dataset:
exploration of chronic hepatitis c infection receiving 24-week interferon-α with ribavirin treatments

Conditions: Chronic Hepatitis C

Summary: the aims of this three-year study are to explore symptom experience and its related factors for the patients with chronic hepatitis c infection receiving interferon-α with ribavirin for 24 weeks and further to predict the relative risk of failure or occurence of severe side effects which interrupt the treatment.

the antiviral treatment, interferon-α with ribavirin, has been used in treating chronic hepatitis c patients to prevent the development of liver cirrhosis and hepatocellular carcinoma. however, the duration of this treatment needs at least 6 months and severe side effects such as anemia, fatigue, depression with suicidal thoughts can occur at any time throughout the treatment. there has been no study related to the issue of the risk to the population of developing these severe side effects and failing the treatment. therefore, the aims of this three-year study are to explore symptom experience and its related factors for the patients with chronic hepatitis c infection receiving interferon-α with ribavirin for 24 weeks and further to develop a prediction model for individuals to predict the relative risk of failure or occurence of severe side effects which interrupt the treatment. patients will be recruited from outpatients in two hospitals in northern and middle taiwan. a longitudinal study is designed with a one-year follow-up at pre-treatment, and at the 1, 2, 4, 6, 8, 12,16,20, 24 weeks during treatment, and at the 4, 12, 24 weeks of post-treatment. the basic information including the laboratory data, the symptom distress scale, the fatigue symptom inventory, the hospital anxiety and depression scale, mos, and the short-form 12 health-related quality of life questionnaires will be used to assess patients' demographic characteristics, symptom experience, fatigue, depression, anxiety, sleep disturbance, and quality of life during the treatment. three hundred patients will be interviewed within three years. the data will be analyzed using descriptive, independent t-test, pearson's correlation, analysis of variances, generalized estimating equations, logistic regression, and classification tree. we expect this study to explore the characteristics of the population with high risks of treatment failure to severe side effects during treatment in taiwan. in addition, the results can provide the information for clinicians and researchers to tailor interventions to individual needs.

Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis c infection receiving 24-week interferon-α with ribavirin treatments * those who willing to participate in the research * aged above 18 exclusion criteria: * none

Keywords: hepatitis c interferon symptom distress quality of life
hypnosis and virtual reality in bone marrow examination

Conditions: Hematologic Diseases

Summary: the goal of this clinical trial is to compare the effects of hypnosis, virtual reality or their combination in patients undergoing a bone marrow procedure. the main question it aims to answer is whether such interventions may relieve anxiety and other symptoms described by patients undergoing the procedure. before the bone marrow procedure and after being explained on the study and signing informed consent, the nurse will measure vital signs and participants will fill-out a 2-minutes' questionnaire and will be assigned to one of 3 groups: * hearing a 7-minutes hypnotic script via earphones * seeing and hearing virtual images and sounds via a virtual reality device during 7 minutes * none of these after these interventions or 10 minutes after assignation for patients not receiving intervention, patients will fill questionnaires again (about 5 minutes for filling the 2 questionnaires) and vital signs will be measured again. then the bone marrow procedure will be performed. after the bone marrow procedure, the participants will fill-out another 2-minutes questionnaire and vital signs will be measured by the nurse. researchers will compare hypnotic script, virtual reality, their combination or none of them to see if they can affect anxiety and other complaints in patients undergoing a bone marrow procedure.


Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. candidate for a bm examination at the hematology unit 3. ability to answer questionnaires in hebrew, arabic or russian 4. informed consent form signing exclusion criteria: 1. major hearing impairment 2. major visual impairment.

Keywords: bone marrow procedure hematology hypnosis guided imagery virtual reality
aromatherapy effect on pain and anxiety after c-section

Conditions: Post-operative Pain; Post-operative Anxiety

Summary: a prospective randomized triple blinded study conducted in the obstetrics gynecology department of ben arous hospital over a period of four months and 10 days between april 2023 and august 2023. the aim of this study was to evaluate the effectiveness of lavender aromatherapy on postoperative pain and anxiety after cesarean section under spinal anesthesia in tunisian women.


Eligibility criteria:
inclusion criteria: * all women who gave birth by cesarean section under spinal anesthesia in the obstetrics and gynecology department at the ben arous regional hospital who met the following criteria were included in this study: * age between 18 and 45 years old * term of pregnancy at the time of delivery ≥ 37 weeks of gestation. * a minimum level of primary education as a prerequisite to answer the questions (in particular the stai items). * classified asa 1 or 2 of the american society of anesthesiology (asa) classification. * having no history of cancer or chronic pain. * free from any psychiatric pathology. * and having not presented any intra- or post-operative complications. exclusion criteria: the investigators excluded patients in our study: * having given birth to a stillborn or a suffering newborn requiring transfer to neonatal intensive care. * having received painkillers in the post-operative period. * having olfactory disorders. * having a substance abuse problem. * having a known allergy to lavender or other aromatic plants. * who did not agree to participate in the study or who did not continue all stages of the trial.

Keywords: cesarean pain anxiety aromatherapy lavender
dexmedetomidine supplemented analgesia and delirium after hip fracture surgery

Conditions: Elderly; Hip Fracture Surgery; Patient-controlled Analgesia; Dexmedetomidine; Postoperative Delirium

Summary: delirium is common in the elderly after hip fracture surgery, and is associated with worse outcomes. the investigators hypothesize that, for elderly patients after hip fracture surgery, dexmedetomidine supplemented analgesia can reduce the incidence of delirium and improve the long-term outcomes.

delirium is a common complication in patients after hip fracture surgery and is associated with worse outcomes, including prolonged hospital stay, poor functional recovery, decreased cognitive function, increased health care costs, and elevated mortality rate. the etiology of delirium is multifactorial and include severe pain and sleep disturbances after surgery, as well as surgery-related inflammation. dexmedetomidine is a selective alpha 2 receptor agonist. it exerts sedative effects by activating the endogenous sleep-promoting pathway and leads to a state like non-rapid eye movement sleep. it produces analgesic effects by activating the alpha2a adrenergic receptor subtype in the spinal cord. perioperative dexmedetomidine also alleviates the degree of surgery-related inflammation. previous studies showed that, for elderly patients admitted to the intensive care unit after non-cardiac surgery, low-dose dexmedetomidine infusion improved subjective sleep quality and reduced delirium early after surgery; it also increased survival up to 2 years and improved life quality in 3-year survivors. the investigators hypothesize that dexmedetomidine supplemented patient-controlled analgesia can also reduce delirium and improve long-term outcomes in elderly patients after hip fracture surgery.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years but \< 90 years; * scheduled to undergo hip fracture surgery; * planned to use patient-controlled intravenous analgesia (pcia) after surgery. exclusion criteria: * refuse to participate in this study; * preoperative history of schizophrenia, epilepsy, parkinsonism, or myasthenia gravis; * inability to communicate in the preoperative period because of coma, profound dementia or language barrier; * preoperative obstructive sleep apnea (diagnosed sleep apnea syndrome or a stop-bang score ≥3 combined with a serum bicarbonate ≥28 mmol/l); * sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker; * severe hepatic dysfunction (child-pugh class c); * severe renal dysfunction (requirement of renal replacement therapy before surgery); * american society of anesthesiologists physical status \>iv, or estimated survival ≤24 h.

Keywords: elderly hip fracture surgery patient-controlled analgesia dexmedetomidine postoperative delirium
clinical effects of oral trehalose in patients with spinocerebellar ataxia 3

Conditions: Spinocerebellar Ataxia 3

Summary: there are no clinically established treatments which have been proven to delay the disease progression in spinocerebellar ataxia (sca) 3. most available treatments are only for symptom alleviation, and thus the majority of patients will eventually progress to needing and wheel chair and eventually bedridden. as trehalose appear to be potentially promising treatment in sca, the investigators aim to conduct this study using oral trehalose in our genetically confirmed sca 3 patients.

this prospective single arm interventional study involved 13 genetically confirmed spinocerebellar ataxia (sca) 3 patients with no concomitant diabetes, over 6 months. following baseline assessment, patients were instructed to ingest 100g of oral trehalose diluted in 500ml of water or other beverages daily. assessments were performed at baseline, 2, 4 and 6 months using ataxia rating scales (sara, scafi and inas) and eq-5d-3l scale for quality of life assessment.

Eligibility criteria:
inclusion criteria: 1. dna diagnosis of sca 3 in the study subject of his/ her affected family member(s) 2. consent to participate in the study 3. the age of 18 years and older exclusion criteria: 1. unconfirmed sca 3 2. concomitant disorder(s) that affect sara and other ataxia measures used in this study 3. diabetes 4. malabsorption of trehalose underlies intolerance to mushrooms, since the lack of absorption results in diarrhoea and intestinal distress. 5. less than 18 years old
study of silodosin to facilitate passage of urinary stones

Conditions: Ureteral Calculi; Kidney Stones; Urolithiasis

Summary: the purpose of this study is to assess if patients treated with silodosin will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.


Eligibility criteria:
inclusion criteria: * at least 18 years of age or older * male or a non-pregnant, non-lactating female using adequate means of birth control, if not menopausal * have radiopaque unilateral ureteral calculus ≥4mm and ≤10mm in any location of the ureter exclusion criteria: * multiple ureteral calculi, or a solitary kidney, or refractory renal colic, or a non-opaque calculus, or active urinary tract infection, or severe hydronephrosis * history of previous ureteral surgery or ureteral stricture on affected side * history of any of the following conditions: myasthenia gravis, myopathy, spina bifida, spinal cord injury, autonomic nervous system disorder, fibromyalgia, breast cancer * moderate to severe renal impairment or severe liver insufficiency * history of significant postural hypotension * is receiving medication(s) which preclude safe participation in the study or that may produce a confounding effect on the variables under study * history of allergy to alpha-blockers or oxycodone

Keywords: ureteral calculi renal colic ureteral stones kidney stones medical expulsive therapy
efficacy and safety of da5221-t when added to ongoing da5221-b1 and da5221-b2 combination therapy in patients with type 2 diabetes who have inadequate glycemic control

Conditions: Type 2 Diabetes

Summary: this study evaluates the efficacy and safety of adding the sglt-2 inhibitor da5221-t to the combination therapy of da5221-b1 and the dpp-4 inhibitor da5221-b2 in patients with type 2 diabetes who have inadequate blood glucose control. the study focuses on assessing the effectiveness and safety of the triple combination therapy.


Eligibility criteria:
inclusion criteria: 1. patients with type ii diabetes mellitus aged 19 years or older 2. patients who had taken da5221-b1 and da5221-b2(or another dpp-4 inhibitor is allowed) combination therapy at the same dose for at least 8 weeks prior to the screening visit 3. patients with fasting plasma glucose≤270mg/dl at the screening visit 4. patients with 18.5kg/m\^2≤bmi≤40kg/m\^2 at the screening visit 5. patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study exclusion criteria: 1. patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis 2. patients with a medical history of new york heart association(nyha) class iii\~iv heart failure or with congestive heart failure, acute and unstable heart failure 3. patients with severe infectious disease or severe traumatic systemic disorders 4. patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia 5. patients with galactose intolerance, lapp lactase deficiency, glucosegalactose malabsorption
long-term extension study to assess adverse events of oral atogepant tablets in pediatric participants (6 to 17 years of age) with migraine

Conditions: Migraine Prophylaxis

Summary: a migraine is a moderate to severe headache on one side of the head. a migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. a number of treatments are available for adults with migraine but there are limited approved treatments available for participants less than 18 years of age. the main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine. atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of migraine. this is a phase 3, open-label study of atogepant in participants with a history of migraine. participants must have completed participation in another study of atogepant (lead-in study). participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and \>= 15 headache days and \>= 8 migraine days for chronic migraine in the 4-week screening electronic diary (ediary; similar to a smart phone). around 650 participants will be enrolled in the study at approximately 100 sites worldwide. atogepant is a tablet taken once a day by mouth. participants between the ages of 12 and 17 will receive high dose atogepant for 52 weeks. participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 52 weeks. there may be a bigger responsibility for participants in this study. participants will attend regular visits during the study at a hospital or clinic. the effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.


Eligibility criteria:
inclusion criteria: * participants must be between 6 and 17 years of age (inclusive), with a history of episodic (ages 6 to 17) or chronic (ages 12 to 17) migraine. * the participant must have completed the lead-in study m21-201, or the pharmacokinetic (pk) substudy in study m21-201, or the lead-in study m23-712. * weight is \>= 20 kg (44 lbs) and \< 135 kg (298 lbs). * a history of migraine with or without aura consistent with a diagnosis according to the international classification of headache disorders, 3rd edition (ichd-3; 2018) for at least 6 months. exclusion criteria: * have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ichd-3 (2018). * have any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular, or neurologic disease.

Keywords: migraine prophylaxis atogepant qulipta agn-241689
product evaluation for the effectiveness of the clearguard® hd end cap

Conditions: End Stage Renal Disease (ESRD)

Summary: to assess blood stream infections in participants using two fda-cleared devices: clearguard hd end caps compared to the tego® connector with the curostm for tego disinfecting port protector.

prospective, cluster-randomized, open-label, post market, comparative effectiveness evaluation with facilities participating for up to 13 months.

Eligibility criteria:
inclusion criteria: * all patients dialyzing with a central venous catheter exclusion criteria: * known allergy to chlorhexidine
a study of the safety and efficacy of multiple doses of abt-089 in subjects with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to compare the safety and efficacy of 2 mg, 4 mg, and 20 mg of abt-089 bid to placebo in adults with alzheimer's disease.


Eligibility criteria:
inclusion criteria: * current diagnosis of probable alzheimer's disease. * adas-cog score of at least 12 and mmse score of 10 to 26. * non-smoker * must have legally authorized representative and a reliable caregiver. the caregiver and legally authorized representative may be the same person. * fluent in english. exclusion criteria: * use of cholinesterase inhibitors or any other drugs to treat alzheimer's disease in the last 6 weeks. * has clinically significant or uncontrolled medical condition other than alzheimer's disease. * nursing home resident.
dose escalation trial of intra-tumoral injection of nis measles virus in combination with atezolizumab

Conditions: Recurrent Non-Small Cell Lung Cancer

Summary: this a phase 1 study designed to determine the maximum tolerated dose (mtd) and toxicity of attenuated measles virus (mv-nis) combined with atezolizumab in patients with recurrent and metastatic nsclc.

phase 1, dose escalation study of the combination of intra-tumoral mv-nis and systemic atezolizumab in patients with recurrent and metastatic nsclc. after the dose escalation phase of the trial, a dose expansion cohort was planned to further investigate safety, clinical and immune responses at the mtd. a standard 3+3 design was to be used for the dose escalation part of the study. starting at dose level 1, three patients were to be treated per dose level. mv-nis was to be administered once intra-tumorally (it) on day 1 of treatment in 3 escalating dose cohorts, starting at dose level 1 x 10e8

Eligibility criteria:
key inclusion criteria: * diagnosis of metastatic lung cancer, with histologic confirmation of the primary nsclc histology and with at least one lesion amenable for intra-tumoral injection of mv-nis. * patient meets the fda-approved indication for atezolizumab treatment in nsclc. * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1. * ability to provide informed consent. * adequate hematological, liver and kidney function. * must be willing to implement contraception throughout study and for the 8 weeks following last study drug administration. key exclusion criteria: * any of the following prior therapy: chemotherapy ≤ 3 weeks prior to registration. biologic therapy ≤ 4 weeks prior to registration. radiation therapy ≤ 3 weeks prior to registration * other concurrent investigational therapy (utilized for a non-fda-approved indication and in the context of a research investigation). * pregnant women. * nursing women. * men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks following the completion of study drug treatment. * allergy to measles vaccine or history of severe reaction to prior measles vaccination. * history of organ transplantation.

Keywords: lung cancer measles nivolumab opdivo
evaluate the efficacy and safety of insulin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: a study to evaluate the efficacy and safety of human insulin inhalation powder \[also known as air® inhaled insulin\]\[air® is a registered trademark of alkermes,inc.\] in patients with type 2 diabetes who are currently being treated with once daily insulin glargine injections. the present study is intended to determine if mealtime air® insulin may be superior to once-daily insulin glargine injections.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * one or more oral antihyperglycemic medications * once-daily insulin glargine * hba1c greater than or equal to 7.5 and less than or equal to 10.5% * non-smoker exclusion criteria: * taking a tzd dose greater than what is indicated * more than two episodes of severe hypoglycemia during the 6 months prior * have had a lower respiratory infection in the 3 months prior * systemic glucocorticoid therapy * clinical signs or symptoms of liver disease, acute or chronic hepatitis * history of renal transplantation * have an active or untreated malignancy * require more than 150 u/day of insulin glargine
an open-label study examining the long-term safety of exenatide given twice daily to patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of this study is to assess the long-term safety of exenatide in patients with type 2 diabetes who were treated with exenatide in study h8o-mc-gwaa (6-month study) or study h8o-mc-gwad (12-month study). study h8o-mc-gwan serves as an open-ended extension to studies h8o-mc-gwaa and h8o-mc-gwad.


Eligibility criteria:
inclusion criteria: * patients received exenatide therapy in study h8o-mc-gwaa or study h8o-mc-gwad and completed the respective study. exclusion criteria: * patients were excluded or discontinued early from study h8o-mc-gwaa or study h8o-mc-gwad. * patients have received treatment within the last 30 days with a drug, not including exenatide, that has not received regulatory approval for any indication at the time of study entry.

Keywords: diabetes exenatide byetta amylin lilly